# US 8,784,389 B2 · Oxygen supply for implantable medical device

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- Number: US 8,784,389 B2
- Document ID: US8784389B2
- Status: Granted
- Kind: B2
- Application number: 12/551,151
- Filed: 2009-08-31
- Published: 2011-03-03
- Granted: 2014-07-22
- Earliest claimed: 2009-08-31
- Assignees: Beta-O2 Technologies Ltd.
- Applicants: Jacob Stern; Avi Rotem; Yoav Hevron; Yehezkel Bermer
- Inventors: Jacob Stern; Avi Rotem; Yoav Hevron; Yehezkel Bermer
- Web page: https://patentgrep.com/patent/US8784389B2

## CPC

- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61M 5/1582: {Multi-lumen needles}
- A61M 2005/006: {for gases, e.g. CO2}
- A61M 2039/0211: {with multiple chambers in a single site}
- A61M 2039/0217: {at least some chambers being stacked separated by another septum}
- A61M 2202/0208: Oxygen
- A61M 2209/045: for filling, e.g. for filling reservoirs
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A method for replenishing gas in a subcutaneously implanted medical device containing functional cells comprising: inserting at least one needle, adopted to penetrate the skin and connecting a subcutaneously implanted medical device; connecting the inserted at least one needle to a gas replenishing apparatus; extracting gas from a gas reservoir in the implanted device into the gas replenishing apparatus; sensing oxygen level in the extracted gas; calculating the amount of gas needed for replenishing oxygen in the reservoir based on the sensed oxygen level in the extracted gas; and supplying gas from a gas tank in the gas replenishing apparatus to the gas reservoir in the implanted device.

## Claims

### Claim 1

A gas replenishing apparatus for replenishing gas in a subcutaneously implanted medical device containing functional cells comprising:
at least one needle capable of penetrating the skin and connecting to the subcutaneously implanted medical device;
a gas tank holding gas for replenishing gas in said implanted device;
a gas handling sub-system capable of supplying gas from said gas tank into a gas reservoir in said implanted device;
at least one gas sensor selected from: an oxygen sensor sensing oxygen level in gas extracted from said reservoir; and a pressure transducer measuring pressure in said reservoir; and
a processor for controlling said gas handling sub-system in response to reading of said at least one of said oxygen sensor and said pressure transducer,
wherein said gas is capable of extracting gas from said gas reservoir; and said processor is capable of controlling said gas handling sub-system in response to sensed oxygen level in gas extracted from said gas reservoir; wherein said gas handling sub-system comprises a gas pump for extracting gas from said gas reservoir.

### Claim 2 (depends on 1)

The apparatus of claim 1 and further comprising an output valve controlled by said processor, and wherein said output valve is capable of controlling amount of gas supplied from said gas tank into said gas reservoir.

### Claim 3 (depends on 1)

The apparatus of claim 1 wherein said gas sensor is the pressure transducer; and wherein said processor controls said gas handling sub-system in response to sensed pressure in said gas reservoir.

### Claim 4 (depends on 1)

The apparatus of claim 1 and comprising at least one pressure transducer monitoring gas pressure within said gas handling sub-system.

### Claim 5 (depends on 1)

The apparatus of claim 1 wherein said at least one needle is a single needle used for both extracting gas from said gas reservoir and supplying gas from said gas tank into said gas reservoir.

### Claim 6 (depends on 1)

The apparatus of claim 1 wherein said at least one needle is a single needle having a first channel and a second channel, wherein said first channel is used for extracting gas from said gas reservoir, and said second channel is used for supplying gas from said gas tank into said gas reservoir.

### Claim 7 (depends on 6)

The apparatus of claim 6 wherein said first channel and said second channel are coaxial.

### Claim 8 (depends on 1)

The apparatus of claim 1 wherein said at least one needle comprises a first and a second needle, wherein said first needle is used for extracting gas from said gas reservoir and said second needle is used for supplying gas from said gas tank into said gas reservoir.

### Claim 9 (depends on 8)

The apparatus of claim 8 wherein said first needle and said second needle are inserted into a first and a second gas ports of the implanted medical device, respectively.

### Claim 10 (depends on 1)

The apparatus of claim 1 wherein said at least one needle is capable of penetrating a gas port which is an integral part of the implanted medical device.

### Claim 11 (depends on 1)

The apparatus of claim 1 wherein said at least one needle is capable of penetrating a gas port which is connected to the implanted medical device via a flexible tube.

### Claim 12

A method for replenishing gas in a subcutaneously implanted medical device containing functional cells comprising:
inserting at least one needle capable of penetrating the skin and connecting to the subcutaneously implanted medical device;
connecting said at least one needle to a gas replenishing apparatus;
extracting gas from a gas reservoir in the implanted medical device into said gas replenishing apparatus;
sensing oxygen level in the gas extracted from said gas reservoir;
calculating the amount of gas needed for replenishing oxygen in said gas reservoir based on the sensed oxygen level in the extracted gas; and
supplying gas from a gas tank in said gas replenishing apparatus to said gas reservoir in the implanted medical device.

### Claim 13 (depends on 12)

The method of claim 12 wherein the gas in said gas tank comprises at least one gas selected from a group comprising: Oxygen, Nitrogen, Carbon dioxide; water vapor and noble gas.

### Claim 14 (depends on 12)

The method of claim 12 wherein extracting gas from said gas reservoir comprises pumping the gas.

### Claim 15 (depends on 12)

The method of claim 12 wherein supplying gas from the gas tank in said gas replenishing apparatus to said gas reservoir comprises opening an output valve that is controlled by a processor.

### Claim 16 (depends on 12)

The method of claim 12 wherein supplying gas from the gas tank in said gas replenishing apparatus to said gas reservoir comprises operating a gas compressor controlled by a processor.

### Claim 17 (depends on 12)

The method of claim 12 wherein supplying gas from the gas tank in said gas replenishing apparatus to said gas reservoir comprises reducing gas pressure in said gas tank by a pressure regulator.

### Claim 18 (depends on 12)

The method of claim 12 wherein inserting at least one needle comprises inserting a single needle used for both extracting gas from said gas reservoir and supplying gas from said gas tank into said gas reservoir.

### Claim 19 (depends on 12)

The method of claim 12 wherein inserting at least one needle comprises inserting a single needle having a first channel and a second channel, wherein said first channel is used for extracting gas from said gas reservoir, and said second channel is used for supplying gas from said gas tank into said gas reservoir.

### Claim 20 (depends on 12)

The method of claim 12 wherein inserting at least one needle capable of penetrating the skin and connecting to a subcutaneously implanted medical device comprises inserting a first needle and a second needle into a first gas port and a second gas ports of the implanted medical device respectively, wherein said first needle is used for extracting gas from said gas reservoir, and said second needle is used for supplying gas from said gas tank into said gas reservoir.

### Claim 21 (depends on 12)

The method of claim 12 wherein said at least one needle is capable of penetrating a gas port which is an integral part of the implanted medical device.

### Claim 22 (depends on 12)

The method of claim 12 wherein said at least one needle is capable of penetrating a gas port which is connected to the implanted medical device via a flexible tube.

### Claim 23

A method for replenishing gas in a subcutaneously implanted medical device containing functional cells comprising:
inserting at least one needle capable of penetrating skin and connecting to a subcutaneously implanted medical device;
connecting said at least one needle to a gas replenishing apparatus;
measuring a gas pressure in a gas reservoir in the implanted medical device;
calculating the amount of gas needed for replenishing oxygen in said gas reservoir based on sensed pressure in the extracted gas; and
supplying gas from a gas tank in said gas replenishing apparatus to said gas reservoir in the implanted medical device.

### Claim 24

A system for maintaining functional cells in medical device subcutaneously implanted in a patient body comprising:
a gas reservoir provided within the implanted medical device;
a gel layer disposed with a plurality of the functional cells, wherein said gel layer is capable of protecting the functional cells from the body immune system by a first membrane, and wherein said gel layer is capable of receiving oxygen from said gas reservoir; and
at least one gas port provided to the implanted medical device that is capable of receiving replenishing gas supply;
gas replenishing apparatus located outside the patient body and capable of supplying replenishing gas to said gas reservoir through said at least one gas port wherein said gas replenishing apparatus comprising:
at least one needle capable of penetrating the skin of the patient body and connecting to the implanted medical device through said at least one gas port;
a gas tank holding gas for replenishing gas;
a gas handling sub-system capable of supplying gas from said gas tank into said gas reservoir;
at least one gas sensor selected from an oxygen sensor for sensing oxygen level in the gas; and a pressure transducer for measuring pressure in said gas reservoir; and
a processor capable of controlling said gas handling sub-system in response to reading of said at least one of said oxygen sensor and said pressure transducer.

### Claim 25 (depends on 24)

The system of claim 24 wherein said gas handling sub-system is capable of extracting gas from said gas reservoir and said processor is capable of controlling said gas handling sub-system in response to reading oxygen level sensed in the gas.

### Claim 26 (depends on 24)

The system of claim 24 and further comprising at least one hose connecting said at least one needle to said gas replenishing apparatus.

### Claim 27 (depends on 26)

The system of claim 26 wherein said at least one hose is flexible.

### Claim 28 (depends on 24)

The system of claim 24 wherein said implanted device comprises at least a first and a second gas ports, both connected to said gas reservoir.

### Claim 29 (depends on 28)

The system of claim 28 wherein said gas replenishing apparatus comprises a first and a second needle inserted into said first and a second gas ports of said implanted device respectively, wherein said first needle is used for extracting gas from said gas reservoir, and said second needle is used for supplying gas from said gas tank into said gas reservoir.

### Claim 30 (depends on 24)

The system of claim 24 wherein the implanted medical device further comprises a buffer gas chamber located between said gel layer with functional cells and said gas reservoir and wherein said gas reservoir is separated from said gel layer by a second membrane.

### Claim 31 (depends on 30)

The system of claim 30 wherein the implanted medical device comprises at least a first and a second gas port, and wherein said first gas port is connected to said gas reservoir, and said second port is connected to said buffer gas chamber.

### Claim 32 (depends on 30)

The system of claim 30 wherein said gas replenishing apparatus comprises at least a first and a second needle inserted into said at least one gas port wherein said first needle is used for extracting gas from said buffer gas chamber, and said second needle is used for supplying gas from said gas tank into said gas reservoir.

### Claim 33

A gas replenishing apparatus for replenishing gas in a subcutaneously implanted medical device containing functional cells comprising:
at least one needle capable of penetrating the skin and connecting to a subcutaneously implanted medical device;
a gas tank holding gas for replenishing gas in the implanted medical device;
a gas handling sub-system capable of supplying a predetermined amount of gas from said gas tank into a gas reservoir in the implanted medical device and further comprising a timer, wherein said timer is capable of measuring the time elapsed since last gas replenishing, and wherein said predetermined amount of gas is selected according to the elapsed time.

### Claim 34 (depends on 33)

The apparatus of claim 33 wherein said predetermined amount of gas is fixed and wherein time between consecutive gas replenishing is substantially fixed.
